A real‐world evidence study of nabiximols in multiple sclerosis patients with resistant spasticity: Analysis in relation to the newly described ‘spasticity‐plus syndrome’

Patti, Francesco; Chisari, Clara Grazia; Fernández, Óscar; Sarroca, Jorge; Ferrer‐Picón, Elena; Vicente, Francisco Hernández; Silván, Carlos Vila

doi:10.1111/ene.15412

Cited by 15 publications

(13 citation statements)

References 38 publications

(72 reference statements)

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“…The largest clusters were of spasticity, spasms/cramps and pain, and the cluster of those three symptoms plus fatigue. Pain was the symptom most frequently associated with spasticity, as also found in other studies ( 14 , 20 ). In this study, pain was more common in RRMS patients but the difference was not statistically significant.…”

Section: Discussionsupporting

confidence: 87%

“…Patients were mainly women, although the female/male ratio was lower than that reported for Spain and Europe ( 18 ), and had significant physical disability (mean EDSS score of 6.5). The most common MS phenotype was SPMS (65%), as reported in other studies ( 14 , 15 , 19 ). The mean number of symptomatic treatments used by patients increased over time.…”

Section: Discussionsupporting

confidence: 79%

“…However, the effects of analgesic medications are poor to moderate ( 21 ). There is not a single type of pain in MS and many different types have been suggested ( 22 ), including neuropathic pain ( 23 ) such as trigeminal neuralgia ( 14 ). Therefore, pain assessment in MS patients should be multidimensional in order to choose the best treatment ( 21 ) as well as using the fewest number of drugs to avoid polytherapy.…”

Section: Discussionmentioning

confidence: 99%

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Spasticity-Plus syndrome in multiple sclerosis patients in a tertiary hospital in Spain

Goicochea Briceño,

Higueras,

Ruiz Pérez

et al. 2024

Front. Neurol.

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IntroductionSpasticity is a common symptom in multiple sclerosis (MS) and it is often associated with other symptoms such as spasms/cramps and pain. The concept of Spasticity-Plus syndrome takes into account that spasticity is accompanied by one or more symptoms (spasms/cramps, pain, bladder dysfunction, sleep disorders, fatigue and/or tremor). As these symptoms share a common cannabinoid control, therapy acting on cannabinoid receptors may be useful. The main study objectives were to determine the number of MS patients who met Spasticity-Plus syndrome criteria and to identify the most common symptoms.MethodsClinical records of MS patients treated with nabiximols in a tertiary hospital from 2002 to 2022 were reviewed retrospectively.ResultsOf the 73 patients included in the study, 53.4% were women, and most had secondary progressive MS (64.4%). All patients met the criteria for Spasticity-Plus syndrome: 100% had spasticity and at least another symptom. Pain was the second most common symptom (91.8%), followed by spasms/cramps (79.4%), and fatigue (76.7%). Sleep disturbances (p < 0.0001) and tremor (p < 0.027) were more frequent in patients with relapsing–remitting MS than in patients with progressive MS. No statistically significant differences were found for spasticity, pain, spasms/cramps, and fatigue between MS phenotypes. Regarding symptoms clusters, 94.4% of the patients had three or more symptoms. Spasticity was more frequently associated with pain (91.8%) and spasms/cramps (79.4%).ConclusionSpasticity-Plus syndrome was present in all the study population of patients with different MS phenotypes, and treated with nabiximols.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionsupporting

confidence: 79%

Section: Discussionmentioning

confidence: 99%

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Spasticity-Plus syndrome in multiple sclerosis patients in a tertiary hospital in Spain

Goicochea Briceño,

Higueras,

Ruiz Pérez

et al. 2024

Front. Neurol.

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“…The improvement in spasticity‐associated symptoms (e.g. spasms, pain, sleep disturbances) observed with nabiximols in randomized controlled trials and observational studies (Flachenecker et al., 2014b ; Markovà et al., 2019 ; Novotna et al., 2011 ; Vermersch & Trojano, 2016 ; Wade et al., 2004 ) suggested a need to look beyond spasticity itself when assessing clinical benefit in patients with MS. Retrospective analyses of real‐world data have since shown that spasticity‐associated symptoms may ameliorate during nabiximols treatment irrespective of the extent of improvement in a patient's spasticity (Patti et al., 2022 , 2020 ).…”

Section: Introductionmentioning

confidence: 99%

Non‐interventional, prospective, observational study on spasticity‐associated symptom control with nabiximols as add‐on therapy in patients with multiple sclerosis spasticity in Austria

Guger¹,

Hatschenberger²,

Leutmezer

2023

Brain and Behavior

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Background and purpose Randomized controlled trials and observational studies of nabiximols oromucosal spray in patients with multiple sclerosis (MS) spasticity have shown improvement in a range of associated symptoms (pain, spasms, fatigue, bladder dysfunction, and sleep disturbances). This study evaluated the effectiveness and tolerability of add‐on nabiximols in the routine management of patients with MS spasticity in Austria, with a focus on spasticity‐associated symptoms. Methods This was an open, prospective, multicenter, observational, non‐interventional study of patients with MS spasticity receiving add‐on treatment with nabiximols oromucosal spray. Main endpoints were patient‐reported changes from baseline in the frequency (counts) or severity (mean Numerical Rating Scale [NRS] scores) of spasticity‐associated symptoms, and patient‐reported changes from baseline in impairment of daily activities due to spasticity, after 1 and 3 months of nabiximols treatment. No analyses were conducted for statistical significance. Results There were 55 patients in the effectiveness population, and 62 in the safety population. Patients reported clinically relevant reductions from baseline to month 3 in the average number of spasms/day (−68.2%) and number of urinary incontinence episodes (−69.3%) in the week prior to the clinic visit, and reductions in mean 0−10 NRS scores for sleep impairment (−47.2%), fatigue (−26.4%), pain (40.4%), and spasticity severity (39.0%). There was no change from baseline in daily activity impairment due to spasticity. The majority of patients were at least partly satisfied with add‐on nabiximols for spasticity‐associated symptoms. There were 31 adverse events (27 treatment related) reported in 19 patients, with no new safety signals. Conclusions Add‐on nabiximols improved the severity of MS spasticity and a range of spasticity‐associated symptoms during real‐world use in Austria. Nabiximols is an option for patients with MS spasticity who fail first‐line oral antispasticity treatment.

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“…A recent Cochrane review concluded that, compared with placebo, nabiximols probably reduces the severity of MS-related spasticity in the short-term, but the effect on chronic pain, health-related QoL, and drug tolerance are uncertain [37 ▪ ]. A real-world evidence study of nabiximols in MS patients with resistant spasticity showed beneficial effect on spasticity-plus syndrome, that is, spasticity associated with pain, sleep disturbances, and spasm/cramp [38].…”

Section: Treatment Of Spasticitymentioning

confidence: 99%

Spasticity following brain and spinal cord injury: assessment and treatment

Tamburin

Filippetti

Mantovani

et al. 2022

Current Opinion in Neurology

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Purpose of reviewSpasticity is a common sequela of brain and spinal cord injury and contributes to disability, reduces quality of life, and increases economic burden. Spasticity is still incompletely recognized and undertreated. We will provide an overview of recent published data on the definition, assessment, and prediction, therapeutic advances, with a focus on promising new approaches, and telemedicine applications for spasticity.Recent findingsTwo new definitions of spasticity have been recently proposed, but operational criteria should be developed, and test–retest and inter-rater reliability should be explored. Cannabinoids proved to be effective in spasticity in multiple sclerosis, but evidence in other types of spasticity is lacking. Botulinum neurotoxin injection is the first-line therapy for focal spasticity, and recent literature focused on optimizing its efficacy. Several pharmacological, interventional, and nonpharmacological therapeutic approaches for spasticity have been explored but low-quality evidence impedes solid conclusions on their efficacy. The recent COVID-19 pandemic yielded guidelines/recommendations for the use of telemedicine in spasticity.SummaryDespite the frequency of spasticity, robust diagnostic criteria and reliable assessment scales are required. High-quality studies are needed to support the efficacy of current treatments for spasticity. Future studies should explore telemedicine tools for spasticity assessment and treatment.

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A real‐world evidence study of nabiximols in multiple sclerosis patients with resistant spasticity: Analysis in relation to the newly described ‘spasticity‐plus syndrome’

Cited by 15 publications

References 38 publications

Spasticity-Plus syndrome in multiple sclerosis patients in a tertiary hospital in Spain

Spasticity-Plus syndrome in multiple sclerosis patients in a tertiary hospital in Spain

Non‐interventional, prospective, observational study on spasticity‐associated symptom control with nabiximols as add‐on therapy in patients with multiple sclerosis spasticity in Austria

Spasticity following brain and spinal cord injury: assessment and treatment

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